Events

Safety Alert for computerized tomography equipment

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by GE Medical Systems, Llc. || GE Healthcare Japan Corporation || GE Hangwei Medical Systems Co Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1706-237
  • Event Number
    2007EBC-0000590 ; 2008EBC-0002241
  • Date
    2017-06-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=82
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data

Device

computerized tomography equipment
  • Model / Serial
    CT_RT_16_MKE, DISCOVERY 670 NM/CT, LIGHTSPEED VCT, LIGHTSPEED VCT XT, OPTIMA CT520, OPTIMA CT580, OPTIMA CT660
  • Product Description
    The GENERAL ELECTRIC tomography equipment is designed to: obtain, process and offer images of different planes osections of the body taken at different angles and planes by X-ray technology that are reconstructed in the equipment as three-dimensional models of body structures destined to the diagnosis of the whole body and of selected parts of the body in patients of all ages. Obtain, process and offer images of different planes or sections of the body taken at different angles and planes using X-ray technology that are reconstructed in the equipment as three-dimensional models of bodily structures in order to serve as diagnostic tool for diseases, traumas or anomalies, as well as to plan, guide and supervise the treatment. The system can be used as a diagnostic imaging support in minimally invasive procedures, such as biopsies and ablation of tumors and pathologies. The system can acquire anatomical images of ct (computed tomography) that are useful in clinical terms for simulation and treatment planning.
  • Manufacturer
    GE Medical Systems, Llc. || GE Healthcare Japan Corporation || GE Hangwei Medical Systems Co Ltd.

Manufacturer

GE Medical Systems, Llc. || GE Healthcare Japan Corporation || GE Hangwei Medical Systems Co Ltd.